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No longer availableNCT04825626Updated Sep 29, 2025

An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

An expanded access record providing HB-adMSCs in Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Hope Biosciences Research Foundation. No longer available at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Hope Biosciences Research Foundation · Expanded access

Study type
Expanded access
Access type
Individual patients
Sex
All
01

Study summary

This is an Individual Patient Expanded Access IND to evaluate the safety and preliminary efficacy of autologous HB-adMSCs for treating a single patient Chronic Inflammatory Demyelinating Polyneuropathy, CIDP. The expanded access program will include a screening period of up to 28 days, a 44-week treatment period, a safety follow-up at 50, and a 52-week end-of-study visit.

Read the detailed description

An informed consent form will be given to the participant, who will sign before any procedures.

The informed consent form will include information about this expanded access and all the aspects considered during this process. The participant is required to complete the subsequent visits after they have given their informed consent.

  • Visit 1 - Screening during this period, the principal investigator will determine whether the screened participant is eligible and whether the next visit can be scheduled. Once the principal investigator has evaluated the eligibility (up to 28 days), the patient will be scheduled for the first infusion.
  • Visit 2 - Infusion 1 (Baseline): this visit will be a starting point for comparing participant's data. During this visit, the patient will receive the 1st investigational product via intravenous infusion, with rigorous monitoring of vital signs for a total of 2 hours.
  • Visit 3 to 12 - During these visits, the patient will receive intravenous infusions of HB- adMSCs while her vital signs are precisely monitored for a total of 2 hours.
  • Follow-Up Phone Call - During this safety follow-up phone call, the principal investigator will evaluate the safety of the investigational product by conducting several assessments described in the Schedule of Assessments table.
  • End of Study - At the end of the expanded access program visit, the principal investigator will conduct various evaluations to determine the patient's physical condition and assess whether there have been any safety events resulting from the participation in the expanded access program.
02

Conditions studied

  • Chronic Inflammatory Demyelinating Polyneuropathy
03

In context

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

129 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 49 are open to participants now.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Lead sponsor

Hope Biosciences Research Foundation is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Inclusion criteria

  • Patient diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, with documented medical records.

    • Patient must have banked his stem cells at Hope Biosciences LLC.

Exclusion criteria

  • The patient has any active infection requiring medications.

    • The patient has any suicidal ideation during the screening visit or at any point during the study.
05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • BiologicalHB-adMSCs

    Hope Biosciences adipose derived Mesenchymal Stem Cells.

    Also known as: MSCs

06

Where to request access

1 site
  • Hope Biosciences Stem Cell Research Foundation
    Sugar Land, Texas 77478, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT04825626
Lead sponsor
Hope Biosciences Research Foundation
Responsible party
Sponsor
First posted
Apr 1, 2021
Last update
Sep 29, 2025

Study contacts

Djamchid Lotfi, MD
principal investigator · Hope Biosciences Stem Cell Research Foundation
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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